Prospective, Multi-Center, Open Label, Phase Study II of APOC, a New Controlled Release 15mg Octreotide Acetate, for the Treatment of Advanced NETs

#2087

Introduction: Somatostatin analogues (SSAs) are the cornerstone of systemic therapy of advanced NETs. The efficacy controlling hormone release and tumor growth together with the favorable toxicity profile have positioned SSAs as upfront therapy. Despite of second-line therapies including targeted agents, chemotherapy and radiolabeled peptides have demonstrated activity controlling tumor growth, the less favorable toxicity profiles become a usual discussion with patients (pts) to preserve the quality of life (QoL). Additionally, from concordant flow of evidences clinical benefits could be obtained with higher SSAs circulating levels but remain unreachable with current products. APOC is a new controlled release ready-to-use convenient therapeutic, designed to cover specifically these clinical unmet needs.

Aim(s): This prospective, phase II study will evaluate the efficacy and safety of APOC at 15 mg every 2 weeks in pts with advanced G1 and G2 NETs of GEP origin after progression to SSAs.

Materials and methods: The primary hypothesis is whether the addition of APOC improves progression free survival (PFS) rate at 6 months compared with pts treated with targeted agents in prospective phase III trials.

Conference: 15th Annual ENETSConcerence (2018)

Presenting Author: Capdevila J

Authors: Capdevila J, Hernando J, Casanovas O, Lachamp L, Cabello F,

Keywords: Somatostatin analogues, New release mechanism, High doses,

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